Quality management systems — Requirements
質(zhì)量管理體系——要求
1 Scope
范圍
1.1 General
總則
This International Standard specifies requirements for a quality management system where an organization
本標(biāo)準(zhǔn)為有下列需求的組織規(guī)定了質(zhì)量管理體系要求：
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
需要證實(shí)其有能力穩(wěn)定地提供滿足顧客和適用的法律法規(guī)要求的產(chǎn)品；
b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
通過體系的有效應(yīng)用，包括體系持續(xù)改進(jìn)的過程以及保證符合顧客與適用的法律法規(guī)要求，旨在增進(jìn)顧客滿意。
NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.
注：在本標(biāo)準(zhǔn)中，術(shù)語(yǔ)“產(chǎn)品”僅適用于預(yù)期提供給顧客或顧客所要求的產(chǎn)品。
1.2 Application
1.2 應(yīng)用
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
本標(biāo)準(zhǔn)規(guī)定的所有要求是通用的，旨在適用于各種類型、不同規(guī)模和提供不同產(chǎn)品的組織。
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
當(dāng)本標(biāo)準(zhǔn)的任何要求由于組織及其產(chǎn)品的特點(diǎn)不適用時(shí)，可以考慮對(duì)其進(jìn)行刪減。
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
除非刪減僅限于本標(biāo)準(zhǔn)第7章中那些不影響組織提供滿足顧客和適用法律法規(guī)要求的產(chǎn)品的能力或責(zé)任的要求，否則不能聲稱符合本標(biāo)準(zhǔn)。
1 Normative reference
引用標(biāo)準(zhǔn)
The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
下列標(biāo)準(zhǔn)所包含的條文通過在本標(biāo)準(zhǔn)中引用而構(gòu)成本標(biāo)準(zhǔn)的條文。本標(biāo)準(zhǔn)出版時(shí)，新示版本均為有效。所有標(biāo)準(zhǔn)都會(huì)被修訂，使用本標(biāo)準(zhǔn)的各方探討使用下列標(biāo)準(zhǔn)最新版本的可能性。
ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.
ISO9001:2000質(zhì)量管理體系——基礎(chǔ)和術(shù)語(yǔ)
2 Terms and definitions
術(shù)語(yǔ)和定義
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
本標(biāo)準(zhǔn)采用ISO9000中的術(shù)語(yǔ)和定義。
The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:
本標(biāo)準(zhǔn)描述供應(yīng)鏈所使用的以下術(shù)語(yǔ)經(jīng)過了更改，以反映當(dāng)前的使用情況：
supplier organization customer
供方——組織——顧客
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”.
本標(biāo)準(zhǔn)中的術(shù)語(yǔ)“組織”用以取代ISO9001：1994所使用的術(shù)語(yǔ)“供方”，術(shù)語(yǔ)“供方”用以取代術(shù)語(yǔ)“分承包方”。
Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.
本標(biāo)準(zhǔn)中所出現(xiàn)的術(shù)語(yǔ)“產(chǎn)品”，也可指“服務(wù)”。
3 Quality management system
質(zhì)量管理體系
3.1 General requirements
總要求
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
組織應(yīng)按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系，形成文件，加以實(shí)施和保持，并持續(xù)改進(jìn)。
The organization shall
組織應(yīng)：
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
a) 識(shí)別質(zhì)量管理體系所需的過程及其在組織中應(yīng)用（見1.2）
b) determine the sequence and interaction of these processes,
b) 確定這些過程的順序和相互作用；
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
c) 確定為確保這些過程的有效運(yùn)作和控制所需的準(zhǔn)則和方法；
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
d) 確保可以獲得必要的資源和信息，以支持這些過程的運(yùn)作和監(jiān)視；
e) monitor, measure and analyse these processes, and
e) 監(jiān)視、測(cè)量和分析這些過程；
f) implement actions necessary to achieve planned results and continual improvement of these processes.
f) 實(shí)施必要的措施，以實(shí)現(xiàn)對(duì)這些過程所策劃的結(jié)果和對(duì)這些過程的持續(xù)改進(jìn)。
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
組織應(yīng)按本標(biāo)準(zhǔn)的要求管理這些過程。
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
針對(duì)組織所選擇的任何影響產(chǎn)品符合要求的外包過程組織應(yīng)確保對(duì)其實(shí)施控制，對(duì)此類外包過程的控制應(yīng)在質(zhì)量管理體系加以識(shí)別。
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
注：上述質(zhì)量管理體系所需的過程應(yīng)當(dāng)包括與管理活動(dòng)、資源提供、產(chǎn)品實(shí)現(xiàn)和測(cè)量有關(guān)的過程。
3.2 Documentation requirements
4.2 文件要求
3.2.1 General
4.2.1 總則
The quality management system documentation shall include
質(zhì)量管理體系文件應(yīng)包括：
a) documented statements of a quality policy and quality objectives,
a) 形成文件的質(zhì)量方針和質(zhì)量目標(biāo)；
b) a quality manual,
b) 質(zhì)量手冊(cè)；
c) documented procedures required by this International Standard,
c) 本標(biāo)準(zhǔn)所要求的形成文件的程序；
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,and
d) 組織為確保其過程有效策劃、運(yùn)作和控制所需的文件；
e) records required by this International Standard (see 4.2.4).
e) 本標(biāo)準(zhǔn)所要求的記錄（見4.2.4）。
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.
注：
1、本標(biāo)準(zhǔn)出現(xiàn)“形成文件的程序”之處，即要求建立該程序，形成文件，并加以實(shí)施和保持。
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to
2、不同組織的質(zhì)量管理體系文件的多少與詳略程度取決于：
a) the size of organization and type of activities,
a) 組織的規(guī)模和活動(dòng)的類型；
b) the complexity of processes and their interactions, and
b) 過程及其相互作用的復(fù)雜程度；
c) the competence of personnel.
c) 人員的能力。
NOTE 3 The documentation can be in any form or type of medium.
3、文件可采用任何形式或類型的媒體
3.2.2 Quality manual
4.2.2 質(zhì)量手冊(cè)
The organization shall establish and maintain a quality manual that includes
組織應(yīng)編制和保持質(zhì)量手冊(cè)，質(zhì)量手冊(cè)包括：
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
a) 質(zhì)量管理體系的范圍，包括任何刪減的細(xì)節(jié)與合理性（見1.2）；
b) the documented procedures established for the quality management system, or reference to them, and
b) 為質(zhì)量管理體系編制的形成文件的程序或?qū)ζ湟?/p>
c) a description of the interaction between the processes of the quality management system.
c) 質(zhì)量管理體系過程之間的相互作用的表述
3.2.3 Control of documents
4.2.3 文件控制
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
質(zhì)量管理體系所要求的文件應(yīng)予以控制。記錄是一種特殊類型的文件，應(yīng)依據(jù)4.2.4的要求進(jìn)行控制。
A documented procedure shall be established to define the controls needed:
應(yīng)編制形成文件的程序，以規(guī)定以下方面所需的控制：
a) to approve documents for adequacy prior to issue,
a) 文件發(fā)布前得到批準(zhǔn)，以確保文件是充分與適宜的
b) to review and update as necessary and re-approve documents,
b) 必要時(shí)對(duì)文件進(jìn)行評(píng)審與更新，并再次批準(zhǔn)；
c) to ensure that changes and the current revision status of documents are identified,
c) 確保文件的更改和現(xiàn)行修訂狀態(tài)得到識(shí)別；
d) to ensure that relevant versions of applicable documents are available at points of use,
d) 確保在使用處可獲得有關(guān)版本的適用文件
e) to ensure that documents remain legible and readily identifiable,
e) 確保文件保持清晰、易于識(shí)別；
f) to ensure that documents of external origin are identified and their distribution controlled, and
f) 確保外來(lái)文件得到識(shí)別，并控制其分發(fā)；
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
g) 防止作廢文件的非預(yù)期使用，若因任何原因而保留作廢文件時(shí)，對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí)。
3.2.4 Control of records
4.2.4記錄的控制
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
應(yīng)建立并保持記錄，以提供符合要求和質(zhì)量管理體系有效運(yùn)行的證據(jù)。記錄應(yīng)保持清晰、易于識(shí)別和檢索。應(yīng)編制形成文件的程序，以規(guī)定記錄的標(biāo)識(shí)、貯存、保護(hù)、檢索、保存期限和處置所需的控制。
4 Management responsibility
5 管理職責(zé)
4.1 Management commitment
5.1 管理承諾
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
最高管理者應(yīng)通過以下活動(dòng)，對(duì)其建立、實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)其有效性的承諾提供證據(jù)：
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
a) 向組織傳達(dá)滿足顧客和法律法規(guī)要求的重要性；
b) establishing the quality policy,
b) 制定質(zhì)量方針；
c) ensuring that quality objectives are established,
c) 確保質(zhì)量目標(biāo)的制定；
d) conducting management reviews, and
d) 進(jìn)行管理評(píng)審；
e) ensuring the availability of resources.
e) 確保資源的獲得。
4.2 Customer focus
5.2 以顧客為中心
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).
最高管理者應(yīng)以增進(jìn)顧客滿意為目的，確保顧客的要求得到確定并予以滿足（見7.2.1和8.2.1）
4.3 Quality policy
5.3 質(zhì)量方針
Top management shall ensure that the quality policy
最高管理者應(yīng)確保質(zhì)量方針：
a) is appropriate to the purpose of the organization,
a) 與組織的宗旨相適應(yīng)；
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
b) 包括對(duì)滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾；
c) provides a framework for establishing and reviewing quality objectives,
c) 提供制定和評(píng)審質(zhì)量目標(biāo)的框架；
d) is communicated and understood within the organization, and
d) 在組織內(nèi)得到溝通和理解；
e) is reviewed for continuing suitability.
e) 在持續(xù)適宜性方面得到評(píng)審。
4.4 Planning
5.4 策劃
4.4.1 Quality objectives
5.4.1 質(zhì)量目標(biāo)
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
最高管理者應(yīng)確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo)，質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容（見7.1 a）。質(zhì)量目標(biāo)應(yīng)是可測(cè)量的，并與質(zhì)量方針保持一致。
4.4.2 Quality management system planning
5.4.2質(zhì)量管理體系策劃
Top management shall ensure that
最高管理者應(yīng)確保：
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
a) 對(duì)質(zhì)量管理體系進(jìn)行策劃，以滿足質(zhì)量目標(biāo)以及4.1的要求。
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
b) 在對(duì)質(zhì)量管理體系的變更進(jìn)行策劃和實(shí)施時(shí)，保持質(zhì)量管理體系的完整性。
4.5 Responsibility, authority and communication
5.5 職責(zé)、權(quán)限和溝通
4.5.1 Responsibility and authority
5.5.1 職責(zé)和權(quán)限
Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.
最高管理者方確保組織內(nèi)的職責(zé)、權(quán)限得到規(guī)定和溝通。
4.5.2 Management representative
5.5.2 管理者代表
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
最高管理者應(yīng)指定一名管理者，無(wú)論該成員在其他方面的職責(zé)如何，應(yīng)具有以下方面的職責(zé)和權(quán)限：
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
a) 確保質(zhì)量管理體系所需的過程得到建立、實(shí)施和保持；
b) reporting to top management on the performance of the quality management system and any need for improvement, and
b) 向最高管理者報(bào)告質(zhì)量管理體系的業(yè)績(jī)和任何改進(jìn)的需求
c) ensuring the promotion of awareness of customer requirements throughout the organization.
c) 確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí)。
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
注：管理者代表的職責(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò)。
4.5.3 Internal communication
5.5.3 內(nèi)部溝通
Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
最高管理者應(yīng)確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程，并確保對(duì)質(zhì)量管理體系的有效性進(jìn)行溝通。
4.6 Management review
5.6 管理評(píng)審
4.6.1 General
5.6.1 總則
Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
最高管理者應(yīng)按策劃的時(shí)間間隔評(píng)審質(zhì)量管理體系，以確保其持續(xù)的適宜性、充分性和有效性。評(píng)審應(yīng)包括評(píng)價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要，包括質(zhì)量方針和質(zhì)量目標(biāo)。
Records from management reviews shall be maintained (see 4.2.4).
應(yīng)保持管理評(píng)審的記錄（見4.2.4）
4.6.2 Review input
5.6.2 評(píng)審輸入
The input to management review shall include information on
管理評(píng)審的輸入應(yīng)包括以下方面的信息
a) results of audits,
a) 審核結(jié)果；
b) customer feedback,
b) 顧客反饋；
c) process performance and product conformity,
c) 過程的業(yè)績(jī)和產(chǎn)品的符合性；
d) status of preventive and corrective actions,
d) 預(yù)防和糾正措施的狀況；
e) follow-up actions from previous management reviews,
e) 以往管理評(píng)審的跟蹤措施；
f) changes that could affect the quality management system, and
f) 可能影響質(zhì)量管理體系的變更
g) recommendations for improvement.
g) 改進(jìn)的建議。
4.6.3 Review output
5.6.3 評(píng)審輸出
The output from the management review shall include any decisions and actions related to
管理評(píng)審的輸出應(yīng)包括以下方面有關(guān)的任何決定和措施：
a) improvement of the effectiveness of the quality management system and its processes,
a) 質(zhì)量體系及其過程有效性的改進(jìn)；
b) improvement of product related to customer requirements, and
b) 與顧客要求有關(guān)的產(chǎn)品的改進(jìn)；
c) resource needs.
c) 資源需求。
5 Resource management
6 資源管理
5.1 Provision of resources
6.1 資源的提供
The organization shall determine and provide the resources needed
組織應(yīng)確定并提供以下方面所需的資源：
a) to implement and maintain the quality management system and continually improve its effectiveness, and
a) 實(shí)施、保持質(zhì)量管理體系并持續(xù)改進(jìn)其有效性；
b) to enhance customer satisfaction by meeting customer requirements.
b) 通過滿足顧客要求，增進(jìn)顧客滿意。
5.2 Human resources
6.2 人力資源
5.2.1 General
6.2.1 總則
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
基于適當(dāng)?shù)慕逃�、培�?xùn)、技能和經(jīng)驗(yàn)，從事影響產(chǎn)品質(zhì)量工作的人員應(yīng)是能夠勝任的。
5.2.2 Competence, awareness and training
6.2.2 能力、意識(shí)和培訓(xùn)
The organization shall
組織應(yīng)：
a) determine the necessary competence for personnel performing work affecting product quality,
a) 確定從事影響產(chǎn)品質(zhì)量工作的人員所必要的能力；
b) provide training or take other actions to satisfy these needs,
b) 提供培訓(xùn)或采取其他措施以滿足這些需求；
c) evaluate the effectiveness of the actions taken,
c) 評(píng)價(jià)所采取措施的有效性；
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
d) 確保員工認(rèn)識(shí)到所從事活動(dòng)的相關(guān)性和重要性，以及如何為實(shí)現(xiàn)質(zhì)量目標(biāo)作出貢獻(xiàn)；
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).
e) 保持教育、培訓(xùn)、技能和經(jīng)驗(yàn)的適當(dāng)記錄（見4.2.4）
5.3 Infrastructure
6.3 基礎(chǔ)設(shè)施
The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
組織應(yīng)確定、提供并維護(hù)為達(dá)到產(chǎn)品符合要求所需的基礎(chǔ)設(shè)施。適用時(shí)，基礎(chǔ)設(shè)施包括：
a) buildings, workspace and associated utilities,
a) 建筑物、工作場(chǎng)所和相關(guān)的設(shè)施；
b) process equipment (both hardware and software), and
b) 過程設(shè)備，（硬件和軟件）；
c) supporting services (such as transport or communication).
c) 支持性服務(wù)，（運(yùn)輸或通訊）。
5.4 Work environment
6.4 工作環(huán)境
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
組織應(yīng)確定和管理為達(dá)到產(chǎn)品符合要求所需的工作環(huán)境。
6 Product realization
7 產(chǎn)品實(shí)現(xiàn)
6.1 Planning of product realization
7.1 產(chǎn)品實(shí)現(xiàn)的策劃
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
組織應(yīng)策劃和開發(fā)產(chǎn)品實(shí)現(xiàn)所需的過程。產(chǎn)品實(shí)現(xiàn)的策劃應(yīng)與質(zhì)量管理體系其他過程的要求相一致（見4.1）。
In planning product realization, the organization shall determine the following, as appropriate:
在對(duì)產(chǎn)品實(shí)現(xiàn)進(jìn)行策劃時(shí)，組織應(yīng)確定以下方面的適當(dāng)內(nèi)容：
a) quality objectives and requirements for the product;
a) 產(chǎn)品的質(zhì)量目標(biāo)和要求；
b) the need to establish processes, documents, and provide resources specific to the product;
b) 針對(duì)產(chǎn)品確定過程、文件和資源的需求；
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
c) 產(chǎn)品所要求的驗(yàn)證、確認(rèn)、監(jiān)視、檢驗(yàn)和試驗(yàn)活動(dòng)，以及產(chǎn)品接收準(zhǔn)則；
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
d) 為實(shí)現(xiàn)過程及其產(chǎn)品滿足要求提供證據(jù)所需的記錄。
The output of this planning shall be in a form suitable for the organization's method of operations.
策劃的輸出形式應(yīng)適于組織的運(yùn)作方式。
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
注：
1、對(duì)應(yīng)用于特定產(chǎn)品、項(xiàng)目或合同的質(zhì)量管理體系的過程（包括產(chǎn)品實(shí)現(xiàn)過程）和資源作出規(guī)定的文件可稱之為質(zhì)量計(jì)劃。
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
2、組織也可將7.3的要求應(yīng)用于產(chǎn)品實(shí)現(xiàn)過程的開發(fā)。
6.2 Customer-related processes
7.2 與顧客有關(guān)的過程
6.2.1 Determination of requirements related to the product
7.2.1 與產(chǎn)品有關(guān)的要求的確定
The organization shall determine
組織應(yīng)確定：
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
a) 顧客規(guī)定的要求，包括對(duì)交付及交付后活動(dòng)的要求；
b) requirements not stated by the customer but necessary for specified or intended use, where known,
b) 顧客雖然沒有明示，但規(guī)定的用途或已知的預(yù)期用途所必需的要求；
c) statutory and regulatory requirements related to the product, and
c) 與產(chǎn)品有關(guān)的法律法規(guī)要求；
d) any additional requirements determined by the organization.
d) 組織確定的任何附加要求。
6.2.2 Review of requirements related to the product
7.2.2 與產(chǎn)品有關(guān)的要求的評(píng)審
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
組織應(yīng)評(píng)審與產(chǎn)品有關(guān)的要求。評(píng)審應(yīng)在組織向顧客作出提供產(chǎn)品的承諾之前進(jìn)行（如：提交標(biāo)書、接受合同或訂單及接收合同或訂單的更改），并應(yīng)確保：
a) product requirements are defined,
a) 產(chǎn)品要求得到規(guī)定；
b) contract or order requirements differing from those previously expressed are resolved, and
b) 與以前表述不一致的合同或訂單的要求已予解決；
c) the organization has the ability to meet the defined requirements.
c) 組織有能力滿足規(guī)定的要求。
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
評(píng)審結(jié)果及評(píng)審所引起的措施的記錄應(yīng)予保持（見4.2.4）。
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
若顧客提供的要求沒有形成文件，組織在接收顧客要求前應(yīng)對(duì)顧客要求 進(jìn)行確認(rèn)。
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
若產(chǎn)品要求發(fā)生變更，組織應(yīng)確保相關(guān)文件得到修改，并確保相關(guān)人員知道已變更的要求。
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.
注：在某些情況中，如網(wǎng)上銷售，對(duì)每一個(gè)訂單進(jìn)行正式的評(píng)審可能是不實(shí)際的。而代之對(duì)有關(guān)的產(chǎn)品信息，，如產(chǎn)品目錄、產(chǎn)品廣告內(nèi)容等進(jìn)行評(píng)審。
6.2.3 Customer communication
7.2.3 顧客溝通
The organization shall determine and implement effective arrangements for communicating with customers in relation to
組織應(yīng)對(duì)以下有關(guān)方面確定并實(shí)施與顧客溝通的有效安排：
a) product information,
a) 產(chǎn)品信息；
b) enquiries, contracts or order handling, including amendments, and
b) 問詢、合同或訂單的處理，包括對(duì)其的修改；
c) customer feedback, including customer complaints.
c) 顧客反饋，包括顧客投訴。
6.3 Design and development
7.3 設(shè)計(jì)和開發(fā)
6.3.1 Design and development planning
7.3.1 設(shè)計(jì)和開發(fā)策劃
The organization shall plan and control the design and development of product.
組織應(yīng)對(duì)產(chǎn)品的設(shè)計(jì)和開發(fā)進(jìn)行策劃和控制。
During the design and development planning, the organization shall determine
在進(jìn)行設(shè)計(jì)和開發(fā)策劃時(shí)，組織應(yīng)確定：
a) the design and development stages,
a) 設(shè)計(jì)和開發(fā)階段；
b) the review, verification and validation that are appropriate to each design and development stage, and
b) 適于每個(gè)設(shè)計(jì)和開發(fā)階段的評(píng)審、驗(yàn)證和確認(rèn)活動(dòng)；
c) the responsibilities and authorities for design and development.
c) 設(shè)計(jì)和開發(fā)的職責(zé)和權(quán)限。
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
組織應(yīng)對(duì)參與設(shè)計(jì)和開發(fā)的不同小組之間的接口實(shí)施管理，以確保有效的溝通，并明確職責(zé)分工。
Planning output shall be updated, as appropriate, as the design and development progresses.
隨設(shè)計(jì)和開發(fā)的進(jìn)展，在適當(dāng)時(shí)，策劃的輸出予以更新。
6.3.2 Design and development inputs
7.3.2 設(shè)計(jì)和開發(fā)輸入
Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include
應(yīng)確定與產(chǎn)品要求有關(guān)的輸入，并保持記錄（見4.2.4）。這些輸入應(yīng)包括：
a) functional and performance requirements,
a) 功能和性能要求；
b) applicable statutory and regulatory requirements,
b) 適用的法律法規(guī)要求；
c) where applicable, information derived from previous similar designs, and
c) 適用時(shí)，以前類似設(shè)計(jì)提供的信息
d) other requirements essential for design and development.
d) 設(shè)計(jì)和開發(fā)所必需的其他要求。
These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
應(yīng)對(duì)這些輸入進(jìn)行評(píng)審，以確保其充分性與適宜性，要求應(yīng)完整、清楚，并且不能自相矛盾。
6.3.3 Design and development outputs
7.3.3 設(shè)計(jì)和開發(fā)輸出
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
設(shè)計(jì)和開發(fā)的輸出應(yīng)以能夠針對(duì)設(shè)計(jì)和開發(fā)的輸入進(jìn)行驗(yàn)證的方式提出，并應(yīng)在放行前得到批準(zhǔn)。
Design and development outputs shall
設(shè)計(jì)和開發(fā)輸出應(yīng)：
a) meet the input requirements for design and development,
a) 滿足設(shè)計(jì)和開發(fā)輸入的要求；
b) provide appropriate information for purchasing, production and for service provision,
b) 給出采購(gòu)、生產(chǎn)和服務(wù)提供適當(dāng)?shù)男畔ⅲ?/p>
c) contain or reference product acceptance criteria, and
c) 包含或引用產(chǎn)品接收準(zhǔn)則；
d) specify the characteristics of the product that are essential for its safe and proper use.
d) 規(guī)定對(duì)產(chǎn)品的安全和正常使用所必需的產(chǎn)品特性。
6.3.4 Design and development review
7.3.4 設(shè)計(jì)和開發(fā)評(píng)審
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
在適宜的階段，應(yīng)對(duì)依據(jù)所策劃的安排（見7.3.1）設(shè)計(jì)和開發(fā)進(jìn)行系統(tǒng)的評(píng)審，以便：
a) to evaluate the ability of the results of design and development to meet requirements, and
a) 評(píng)價(jià)設(shè)計(jì)和開發(fā)的結(jié)果滿足要求的能力；
b) to identify any problems and propose necessary actions.
b) 識(shí)別任何問題并提出必要的措施。
Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
評(píng)審的參加者應(yīng)包括與所評(píng)審的設(shè)計(jì)和開發(fā)階段有關(guān)的職能的代表，評(píng)審結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.3.5 Design and development verification
7.3.5 設(shè)計(jì)和開發(fā)驗(yàn)證
Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).
為確保設(shè)計(jì)和開發(fā)輸出滿足輸入的要求，應(yīng)對(duì)依據(jù)所策劃的安排（見7.3.1）設(shè)計(jì)和開發(fā)進(jìn)行驗(yàn)證。驗(yàn)證結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.3.6 Design and development validation
7.3.6 設(shè)計(jì)和開發(fā)確認(rèn)
Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).
為確保產(chǎn)品能夠滿足規(guī)定的使用要求或已知預(yù)期用途的要求，應(yīng)依據(jù)所策劃的安排（見7.3.1）對(duì)設(shè)計(jì)和開發(fā)進(jìn)行確認(rèn)。只要可行，確認(rèn)應(yīng)在產(chǎn)品交付或?qū)嵤┲巴瓿�。確認(rèn)結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.3.7 Control of design and development changes
7.3.7 設(shè)計(jì)和開發(fā)更改的控制
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
應(yīng)識(shí)別設(shè)計(jì)和開發(fā)的更改，并保持記錄，在適當(dāng)時(shí)，應(yīng)對(duì)設(shè)計(jì)和開發(fā)的更改進(jìn)行評(píng)審、驗(yàn)證和確認(rèn)，并在實(shí)施前得到批準(zhǔn)，設(shè)計(jì)和開發(fā)更改的評(píng)審應(yīng)包括評(píng)價(jià)更改對(duì)產(chǎn)品組成部分和已交付產(chǎn)品的影響。
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
更改評(píng)審結(jié)果及任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.4 Purchasing
7.4 采購(gòu)
6.4.1 Purchasing process
7.4.1 采購(gòu)過程
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
組織應(yīng)確保采購(gòu)的產(chǎn)品符合規(guī)定的采購(gòu)要求，對(duì)供方及采購(gòu)的產(chǎn)品控制的類型和程度應(yīng)取決于采購(gòu)的產(chǎn)品對(duì)隨后的產(chǎn)品實(shí)現(xiàn)或最終產(chǎn)品的影響。
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
組織應(yīng)根據(jù)供方按組織的要求提供產(chǎn)品的能力評(píng)價(jià)和選擇供方應(yīng)制定選擇、評(píng)價(jià)和重新評(píng)價(jià)的準(zhǔn)則。評(píng)價(jià)結(jié)果及評(píng)價(jià)所引起的任何必要措施的記錄應(yīng)予保持（見4.2.4）。
6.4.2 Purchasing information
7.4.2 采購(gòu)信息
Purchasing information shall describe the product to be purchased, including where appropriate
采購(gòu)信息應(yīng)表述擬采購(gòu)的產(chǎn)品，適當(dāng)時(shí)包括：
a) requirements for approval of product, procedures, processes and equipment,
a) 產(chǎn)品、程序、過程和設(shè)備批準(zhǔn)的要求；
b) requirements for qualification of personnel, and
b) 人員資格的要求；
c) quality management system requirements.
c) 質(zhì)量管理體系的要求。
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
在與供方溝通前，組織應(yīng)確保規(guī)定的采購(gòu)要求是充分與適宜的。
6.4.3 Verification of purchased product
7.4.3 采購(gòu)產(chǎn)品的驗(yàn)證
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
組織應(yīng)確定并實(shí)施檢驗(yàn)或其他必要的活動(dòng)，以確保采購(gòu)的產(chǎn)品滿足規(guī)定的采購(gòu)要求。
Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
當(dāng)組織或其顧客擬在供方的現(xiàn)場(chǎng)實(shí)施驗(yàn)證時(shí)，組織應(yīng)在采購(gòu)信息中對(duì)擬驗(yàn)證的安排和產(chǎn)品放行的方法作出規(guī)定。
6.5 Production and service provision
7.5 生產(chǎn)和服務(wù)提供
6.5.1 Control of production and service provision
7.5.1 生產(chǎn)和服務(wù)提供的控制
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
組織應(yīng)策劃并在受控條件下進(jìn)行生產(chǎn)和服務(wù)提供，適用時(shí)，受控條件應(yīng)包括：
a) the availability of information that describes the characteristics of the product,
a) 獲得表述產(chǎn)品特性的信息；
b) the availability of work instructions, as necessary,
b) 獲得作業(yè)指導(dǎo)書；
c) the use of suitable equipment,
c) 使用適宜的設(shè)備；
d) the availability and use of monitoring and measuring devices,
d) 獲得和使用監(jiān)視和測(cè)量裝置；
e) the implementation of monitoring and measurement, and
e) 實(shí)施監(jiān)視和測(cè)量；
f) the implementation of release, delivery and post-delivery activities.
f) 放行、交付和交付后活動(dòng)的實(shí)施。
6.5.2 Validation of processes for production and service provision
7.5.2 生產(chǎn)和服務(wù)提供過程的確認(rèn)
The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.
當(dāng)生產(chǎn)和服務(wù)提供過程的輸出不能由后續(xù)的監(jiān)視或測(cè)量加以驗(yàn)證時(shí)，組織應(yīng)對(duì)任何這樣的過程實(shí)施確認(rèn)。這包括僅在產(chǎn)品使用或服務(wù)已交付之后問題才顯現(xiàn)的過程。
Validation shall demonstrate the ability of these processes to achieve planned results.
確認(rèn)應(yīng)證實(shí)這些過程實(shí)現(xiàn)所策劃的結(jié)果的能力。
The organization shall establish arrangements for these processes including, as applicable
組織應(yīng)規(guī)定確認(rèn)這些過程的安排，適用時(shí)包括：
a) defined criteria for review and approval of the processes,
a) 為過程的評(píng)審和批準(zhǔn)所規(guī)定的準(zhǔn)則；
b) approval of equipment and qualification of personnel,
b) 設(shè)備的認(rèn)可和人員資格的鑒定；
c) use of specific methods and procedures,
c) 使用特定的方法和程序；
d) requirements for records (see 4.2.4), and
d) 記錄的要求（見4.2.4）；
e) revalidation.
e) 再確認(rèn)。
6.5.3 Identification and traceability
7.5.3 標(biāo)識(shí)和可追溯性
Where appropriate, the organization shall identify the product by suitable means throughout product realization.
適當(dāng)時(shí)，組織應(yīng)在產(chǎn)品實(shí)現(xiàn)的全過程中使用適宜的方法識(shí)別產(chǎn)品
The organization shall identify the product status with respect to monitoring and measurement requirements.
組織應(yīng)針對(duì)監(jiān)視和測(cè)量要求識(shí)別產(chǎn)品的狀態(tài)。
Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).
在有可追溯性要求的場(chǎng)合，組織應(yīng)控制并記錄產(chǎn)品的唯一性標(biāo)識(shí)（見4.2.4）。
NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.
注：在某些行業(yè)，技術(shù)狀態(tài)管理是保持標(biāo)識(shí)和可追溯性的一種方法。
6.5.4 Customer property
7.5.4 顧客財(cái)產(chǎn)
The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).
組織應(yīng)愛護(hù)在組織控制下或組織使用的顧客財(cái)產(chǎn)。組織應(yīng)識(shí)別、驗(yàn)證、保護(hù)和維護(hù)供其使用或構(gòu)成產(chǎn)品一部分的顧客財(cái)產(chǎn)。若顧客財(cái)產(chǎn)發(fā)生丟失、損壞或發(fā)現(xiàn)不適用的情況時(shí)，應(yīng)報(bào)告顧客，并保持記錄（見4.2.4）。
NOTE Customer property can include intellectual property.
注：顧客財(cái)產(chǎn)可包括知識(shí)產(chǎn)權(quán)。
6.5.5 Preservation of product
7.5.5 產(chǎn)品防護(hù)
The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
在內(nèi)部處理和交付到預(yù)定的地點(diǎn)其間，組織應(yīng)針對(duì)產(chǎn)品的符合性提供防護(hù)，這種防護(hù)應(yīng)包括標(biāo)識(shí)、搬運(yùn)、包裝、貯存和保護(hù)。防護(hù)也應(yīng)適用于產(chǎn)品的組成部分。
6.6 Control of monitoring and measuring devices
7.6 監(jiān)視和測(cè)量裝置的控制
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).
組織應(yīng)確定需實(shí)施的監(jiān)視和測(cè)量以及所需的監(jiān)視和測(cè)量裝置，提供證據(jù)，為產(chǎn)品符合確定的要求（見7.2.1）。
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
組織應(yīng)建立過程，以確保監(jiān)視和測(cè)量活動(dòng)可行并以與監(jiān)視和測(cè)量的要求相一致的方式實(shí)施。
Where necessary to ensure valid results, measuring equipment shall
當(dāng)有必要確保結(jié)果有效的場(chǎng)合時(shí)，測(cè)量設(shè)備應(yīng)：
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
a) 對(duì)照能溯源到國(guó)際或國(guó)家標(biāo)準(zhǔn)的測(cè)量標(biāo)準(zhǔn)，按照規(guī)定的時(shí)間間隔或在使用前進(jìn)行校準(zhǔn)或檢定。當(dāng)不存在上述標(biāo)準(zhǔn)時(shí)，應(yīng)記錄校準(zhǔn)或檢定的依據(jù)；
b) be adjusted or re-adjusted as necessary;
b) 必要時(shí)進(jìn)行調(diào)整或再調(diào)整；
c) be identified to enable the calibration status to be determined;
c) 得到識(shí)別，以確定其校準(zhǔn)狀態(tài)；
d) be safeguarded from adjustments that would invalidate the measurement result;
d) 防止可能使測(cè)量結(jié)果失效的調(diào)整；
e) be protected from damage and deterioration during handling, maintenance and storage.
e) 在搬運(yùn)、維護(hù)和貯存期間防止損壞或失效；
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
此外，當(dāng)發(fā)現(xiàn)設(shè)備不符合要求時(shí)，組織應(yīng)對(duì)以往測(cè)量結(jié)果的有效性進(jìn)行評(píng)價(jià)和記錄。組織應(yīng)對(duì)該設(shè)備和任何受影響的產(chǎn)品采取適當(dāng)?shù)拇胧�。校�?zhǔn)和驗(yàn)證結(jié)果的記錄應(yīng)予保持（見4.2.4）。
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
當(dāng)用于規(guī)定要求的監(jiān)視和測(cè)量時(shí)，計(jì)算機(jī)軟年滿足預(yù)期用途的能力應(yīng)予以確認(rèn)，確認(rèn)應(yīng)在初次使用前進(jìn)行，并在必要時(shí)予以重新確認(rèn)。
NOTE See ISO 10012-1 and ISO 10012-2 for guidance.
注：作為指南，參見ISO 10012-1和ISO 10012-2。
7 Measurement, analysis and improvement
8 測(cè)量、分析和改進(jìn)
7.1 General
8.1 總則
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
組織應(yīng)策劃并實(shí)施以下方面所需的監(jiān)視、測(cè)量、分析和改進(jìn)過程：
a) to demonstrate conformity of the product,
a) 證實(shí)產(chǎn)品的符合性；
b) to ensure conformity of the quality management system, and
b) 確保質(zhì)量管理體系的符合性；
c) to continually improve the effectiveness of the quality management system.
c) 持續(xù)改進(jìn)質(zhì)量管理體系的有效性。
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
這應(yīng)包括對(duì)統(tǒng)計(jì)技術(shù)在內(nèi)的適用方法及其應(yīng)用程度的確定。
7.2 Monitoring and measurement
8.2 監(jiān)視和測(cè)量
7.2.1 Customer satisfaction
8.2.1 顧客滿意
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.
作為對(duì)質(zhì)量管理體系業(yè)績(jī)的一種測(cè)量，組織應(yīng)監(jiān)視顧客關(guān)于組織是否滿足其要求的感受的相關(guān)信息，并確定獲取和利用這種信息的方法。
7.2.2 Internal audit
8.2.2 內(nèi)部審核
The organization shall conduct internal audits at planned intervals to determine whether the quality management system
組織應(yīng)按策劃的時(shí)間間隔進(jìn)行內(nèi)部審核，以確定質(zhì)量管理體系是否：
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
a) 符合策劃的安排（見7.1）、本標(biāo)準(zhǔn)的要求以及組織所確定的質(zhì)量管理體系的要求；
b) is effectively implemented and maintained.
b) 得到有效實(shí)施與保持。
An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
考慮擬審核的過程和區(qū)域的狀況和重要性以及以往審核的結(jié)果，組織應(yīng)對(duì)審核方案進(jìn)行策劃。應(yīng)規(guī)定審核的準(zhǔn)則、范圍、頻次和方法。審核員的選擇和審核的實(shí)施應(yīng)確保審核過程的客觀性和公正性。
Auditors shall not audit their own work.
審核員不應(yīng)審核自己的工作。
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.
策劃和實(shí)施審核以及報(bào)告結(jié)果和保持記錄（見4.2.4）的職責(zé)和要求應(yīng)在形成文件的程序中作出規(guī)定。
The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).
負(fù)責(zé)受審區(qū)域的管理者應(yīng)確保及時(shí)采取措施，以消除向發(fā)現(xiàn)和不合格及其原因。跟蹤活動(dòng)應(yīng)包括對(duì)所采取措施的驗(yàn)證和驗(yàn)證結(jié)果的報(bào)告（見8.5.2）。
NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.
注：作為指南，參見ISO 10011-1, ISO 10011-2 和 ISO 10011-3。
7.2.3 Monitoring and measurement of processes
8.2.3 過程的監(jiān)視和測(cè)量
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality anagement system processes. These methods shall demonstrate the ability of the processes to achieve planned esults. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to nsure conformity of the product.
組織應(yīng)采用適宜的方法對(duì)質(zhì)量管理體系過程進(jìn)行監(jiān)視，并在適用時(shí)進(jìn)行測(cè)量。這些方法應(yīng)證實(shí)過程實(shí)現(xiàn)所策劃的結(jié)果的能力。當(dāng)未能達(dá)到所策劃的結(jié)果時(shí)，應(yīng)采取適當(dāng)?shù)募m正和糾正措施，以確保產(chǎn)品的符合性。
7.2.4 Monitoring and measurement of product
8.2.4 產(chǎn)品的監(jiān)視和測(cè)量
The organization shall monitor and measure the characteristics of the product to verify that product requirements ave been met. This shall be carried out at appropriate stages of the product realization process in accordance with he planned arrangements (see 7.1).
組織應(yīng)對(duì)產(chǎn)品的特性進(jìn)行監(jiān)視和測(cè)量，以驗(yàn)證產(chǎn)品要求已得到滿足。這種監(jiān)視和測(cè)量應(yīng)依據(jù)所策劃的安排（見7.1），在產(chǎn)品實(shí)現(xiàn)過程的適當(dāng)階段進(jìn)行。
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) uthorizing release of product (see 4.2.4).
應(yīng)保持符合接收準(zhǔn)則的證據(jù)。記錄應(yīng)指明有權(quán)放行產(chǎn)品的人員（見4.2.4）。
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been atisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer.
除非得到有關(guān)授權(quán)人員的批準(zhǔn)，適用時(shí)得到顧客的批準(zhǔn)，否則在策劃的安排（見7.1）已圓滿完成之前，不能放行產(chǎn)品和交付服務(wù)。
7.3 Control of nonconforming product
8.3 不合格品控制
The organization shall ensure that product which does not conform to product requirements is identified and ontrolled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for ealing with nonconforming product shall be defined in a documented procedure.
組織應(yīng)確保不符合產(chǎn)品要求的產(chǎn)品得到識(shí)別和控制，以防止其非預(yù)期的使用或交付。不合格品控制以及不合格品處置的有關(guān)職責(zé)和權(quán)限應(yīng)在形成文件的程序中作出規(guī)定。
The organization shall deal with nonconforming product by one or more of the following ways:
組織應(yīng)通過下列一種或幾種途徑，處置不合格品。
a) by taking action to eliminate the detected nonconformity;
a) 采取措施，消除發(fā)現(xiàn)的不合格；
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by he customer;
b) 經(jīng)有關(guān)授權(quán)人員批準(zhǔn)，適用時(shí)經(jīng)顧客批準(zhǔn)，讓步使用、放行或接收不合格品；
c) by taking action to preclude its original intended use or application.
c) 采取措施，防止其原預(yù)期的使用或應(yīng)用。
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
應(yīng)保持不合格的性質(zhì)以及隨后所采取的任何措施的記錄，包括所批準(zhǔn)的讓步的記錄（見4.2.4）。
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
應(yīng)對(duì)糾正后的產(chǎn)品再次進(jìn)行驗(yàn)證，以證實(shí)符合要求。
When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
當(dāng)在交付或開始使用后發(fā)現(xiàn)產(chǎn)品不合格時(shí)，組織應(yīng)采取與不合格的影響或潛在影響的程度相適應(yīng)的措施。
7.4 Analysis of data
8.4 數(shù)據(jù)分析
The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
組織應(yīng)確定、收集和分析適當(dāng)?shù)臄?shù)據(jù)，以證實(shí)質(zhì)量管理體系的適宜性和有效性，并評(píng)價(jià)在何處可以持續(xù)改進(jìn)質(zhì)量管理體系的有效性。這應(yīng)包括來(lái)自監(jiān)視和測(cè)量的結(jié)果以及其他有關(guān)來(lái)源的數(shù)據(jù)。
The analysis of data shall provide information relating to
數(shù)據(jù)分析應(yīng)提供有關(guān)以下方面的信息：
a) customer satisfaction (see 8.2.1),
a) 顧客滿意（見8.2.1）；
b) conformity to product requirements (see 7.2.1),
b) 與產(chǎn)品要求的符合性（見7.2.1）；
c) characteristics and trends of processes and products including opportunities for preventive action, and
c) 過程和產(chǎn)品的特性趨勢(shì)，包括采取預(yù)防措施的機(jī)會(huì)；
d) suppliers.
d) 供方。
7.5 Improvement
8.5 改進(jìn)
7.5.1 Continual improvement
8.5.1 持續(xù)改進(jìn)
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
組織應(yīng)利用質(zhì)量方針、質(zhì)量目標(biāo)、審核結(jié)果、數(shù)據(jù)分析、糾正和預(yù)防措施以及管理評(píng)審，持續(xù)改進(jìn)質(zhì)量管理體系的有效性。
7.5.2 Corrective action
8.5.2 糾正措施
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.
組織應(yīng)采取措施，以消除不合格的原因，防止不合格的再發(fā)生。
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
糾正措施應(yīng)與所遇到的不合格的影響程度相適應(yīng)。
A documented procedure shall be established to define requirements for
應(yīng)編制形成文件的程序，以規(guī)定以下方面的要求：
a) reviewing nonconformities (including customer complaints),
a) 評(píng)審不合格（包括顧客投訴）；
b) determining the causes of nonconformities ,
b) 確定不合格的原因；
c) evaluating the need for action to ensure that nonconformities do not recur,
c) 評(píng)價(jià)確保不合格不再發(fā)生的措施的需求；
d) determining and implementing action needed,
d) 確定和實(shí)施所需的措施；
e) records of the results of action taken (see 4.2.4), and
e) 記錄所采取措施的結(jié)果（見4.2.4）；
f) reviewing corrective action taken.
f) 評(píng)審所采取的糾正措施。
7.5.3 Preventive action
8.5.3 預(yù)防措施
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
組織應(yīng)確定措施，以消除潛在不合格的原因，防止不合格的發(fā)生。預(yù)防措施應(yīng)與潛在問題的影響程度相適應(yīng)。
A documented procedure shall be established to define requirements for
應(yīng)編制形成文件的程序，以規(guī)定以下方面的要求：
a) determining potential nonconformities and their causes,
a) 確定潛在不合格及其原因；
b) evaluating the need for action to prevent occurrence of nonconformities,
b) 評(píng)價(jià)防止不合格發(fā)生的措施的需求；
c) determining and implementing action needed,
c) 確定并實(shí)施所需的措施；
d) records of results of action taken (see 4.2.4), and
d) 記錄所采取措施的結(jié)果（見4.2.4）；
e) reviewing preventive action taken.
e) 評(píng)審所采取的預(yù)防措施。
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